What will happen to clinical trials post-Brexit?

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Gene Matthews (pictured) is the lead partner in the clinical trials team at Leigh Day where he is assisted by paralegal Nancy Williams.

Our article published today in Clinical Risk journal examines the status of EU Regulation 536/2014 in the wake of Brexit. This Regulation is designed to streamline the administrative provisions governing the conduct of clinical trials within the Eurozone through the introduction of a single application portal for companies that wish to obtain authorisation to conduct clinical trials. Notwithstanding this procedural change, the Regulations appear to affirm recognised principles of patient rights and safety and the importance of conducting clinical trials that generate reliable data. Transparency is promoted through the creation of a publicly accessible database containing all the information regarding the conduct of a clinical trial. This is evident through safeguards such as the rigorous reporting and notification obligations that are placed upon sponsors of clinical trials and the obligation placed upon host member states to ensure adequate damage compensation for trial participants through the creation of an insurance guarantee or an equivalent system.

The triggering of article 50 on 29 March 2017 has set the UK firmly on course for Brexit. Brexit will take place after the implementation of the Regulation which is scheduled to take practical effect across Europe by the end of 2017 at the earliest and no later than October 2018. Therefore, the Regulation will be protected by the Great Repeal Bill which will copy and paste all existing EU law into UK law on the date that Brexit takes effect. However, the status of the Regulations in the post Brexit landscape is ambiguous. There are several options which are available to the UK.

Opting in
The Regulations capture the momentum for increasing harmonisation and transparency of the conduct of clinical trial within the EU. Therefore, choosing to preserve this legal act will maintain the status quo and enable the UK to share the supposed benefits that will arise from increased co-operation between EU member states. Moreover, it will enable the UK to take part in multi-centre trials with a European element without having to overcome administrative hurdles.

Opting out
The UK could decide to distance itself from the EU and develop its own national regulatory regime. This could mean that authorisation to conduct clinical trials would be subject to a freestanding application process to the Medicines and Healthcare products Regulatory Agency (MHRA). However, taking this step would require significant planning to avoid any adverse implications that are likely to arise from any uncertainty surrounding the nature of the new UK regulatory framework. Moreover, there several questions that arise – What approach will the UK government wish to take? Will the interests of Pharmaceutical companies prevail over those of trial participants? In other words, will patient rights be sacrificed at the altar of commerciality?

Conclusion
The future status of the EU Regulations within the post Brexit legal framework is hazy. The UK government will need to determine whether it wishes to remain in sync with our European neighbours or whether we wish to navigate our own course. As the deadline to Brexit approaches, it is hoped that the mist of uncertainty will clear